510(k) K161548
K161548 is an FDA 510(k) premarket notification submitted by Southern Implants (Pty), Ltd. for the device "Osseointegrated Fixtures". The FDA issued a decision of Substantially Equivalent on December 1, 2016. The device falls under product code FZE (Prosthesis, Nose, Internal), a Class II device regulated under 21 CFR 878.3680. Southern Implants (Pty), Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2016
- Date Received
- June 3, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Nose, Internal
- Device Class
- Class II
- Regulation Number
- 878.3680
- Review Panel
- SU
- Submission Type